The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet)

Seoul St. Mary's Hospital

Status: Enrolling

Conditions: Colonic Polyps

Treatments: Device: ClearCoajet

Study type: Interventional

Funder types: Other

Identifiers

NCT05737017

Coajet_LGI

Details and patient eligibility

About

The ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure. In this study, the investigators examine the hemostatic effect of ClearCoajet on intraprocedural bleeding during endoscopic mucosal resection or endoscopic submucosal dissection for colorectal sessile polyps or lateral growth tumors larger than 1.5 cm. The investigators also aim to compare the delayed bleeding and recurrence rates between the ClearCoajet group and the control group.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with colorectal sessile polyps or lateral growth tumors larger than 1.5 cm

Exclusion criteria

• Pedunculated polyp
• Patients with coagulopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

The ClearCoajet group

Experimental group

Description:

During the endoscopic resection procedures, the ClearCoajet will be used for injection and initial hemostasis for intraprocedural bleeding.

Treatment:

Device: ClearCoajet

The control group

Active Comparator group

Description:

During the endoscopic resection procedures, the conventional injector will be used for injection.

Treatment:

Device: ClearCoajet